Overview

Effect of Rosuvastatin on Amnesia and Orientation Through Galveston Outcome Amnesia Test in Moderate Head Injury

Status:
Completed
Trial end date:
2007-10-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether rosuvastatin is effective in the management of moderate head injury by improving amnesia and orientation.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Universidad Autonoma de San Luis Potosí
Collaborators:
AstraZeneca
Hospital Central "Dr. Ignacio Morones Prieto"
Treatments:
Rosuvastatin Calcium
Criteria
Inclusion Criteria:

- Man or woman >16 and <50 years with HI less 24 hours in progression and Glasgow
between 9 y 12.

- Man or woman >16 and <50 years with HI and Glasgow l3, with lesions in TC scan.

- Acceptance of family to participate (first grade).

Exclusion Criteria:

- History of HI with disability

- History of neurological or psychiatric disease with disability.

- Administration 24 hrs previous of: fibrates, niacin, ciclosporin, azoles, macrolides,
inhibitors of protease, nefazodone, verapamil, diltiazem,amiodarone.

- Existence of systemic injury with life in compromise (massive bleeding, exposition of
bone in fracture, hepatic or splenic laceration or in great vessels and shock).

- Administration of THAM, mannitol, barbiturates, corticosteroids, scavengers of free
radicals, inhibitors of lipidic peroxidation, indometacin, calcium antagonist,
antagonists of neurotransmitters

- Existence of intracranial lesion which needs surgery.

- Lesions not classifiable or in brainstem.

- Allergy to the drug.

- Hepatopathy or myopathy (or) history of this, or clinical data of hepatic disease.

- Management previous in other Hospital.

- Pregnancy